ISRCTN - ISRCTN70408620: A study of self-administered Misoprostol to prevent bleeding after childbirth in the community (MamaMiso)

Plain English Summary

Background and study aims
Heavy bleeding after childbirth, known as postpartum haemorrhage (PPH), is a major cause of maternal death in the developing world. PPH can be prevented using uterotonic drugs, which cause the uterus (womb) to contract. Misoprostol can be used to prevent PPH as it is affordable, has a long shelf-life, and can be taken by mouth (orally). Currently misoprostol is mostly used in healthcare facilities and self-administration at home is not promoted. The aim of this study is to assess the effectiveness and safety of misoprostol tablets taken immediately after home delivery for the prevention of PPH.

Who can participate?
Pregnant women (more than 34 weeks gestation) living in the participating villages of Mbale district of Eastern Uganda.

What does the study involve?
Participants are randomly allocated to be given either a trial pack of misoprostol or placebo (dummy) tablets to be self-administered orally after delivery. Participants are trained on how to take the pills following delivery and a picture guide will also be included with the pills.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
Liverpool Women's Hospital (UK).

When is the study starting and how long is it expected to run for?
January 2012 to January 2015.

Who is funding the study?
Bill and Melinda Gates Foundation (USA).

Who is the main contact?
Prof. Andrew Weeks
aweeks@liv.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Andrew Weeks

ORCID ID

Contact details

International Maternal Health
Sanyu Research Unit
Department of Women's and Children's Health
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom
+44 (0)151 706 4101
aweeks@liv.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

v5.6 10/07/2011

Study information

Scientific title

A pilot study of self-administered Misoprostol to prevent bleeding after childbirth in the community (MamaMiso)

Acronym

Study hypothesis

Postpartum hemorrhage (PPH) is a major cause of maternal death in the developing world. An important strategy in the prevention of deaths is the use of uterotonic drugs for PPH prophylaxis. Misoprostol has been recognized as an option for preventing PPH as it is economical, heat stable, has a long shelf-life, and can be taken orally.

We envisage that the use of self-administered misoprostol after home births among mothers would be associated with a peri-partum fall in hemoglobin value of over 20% (the outcome of a fall of 2g/dl will also be tested in the pilot).

The objective of the main study will be to assess the effectiveness and safety of antenatal administration of misoprostol tablets (600mcg) for self administration immediately following home delivery for the prevention of postpartum haemorrhage. The objectives of the pilot study are to test the integrity of the study protocol, to test the randomization procedure, to assess the acceptability of the intervention, to test the logistics of follow-up, to test the data collection forms, to validate the quality of life questionnaire in this population and to determine the recruitment rate to help study planning.

Ethics approval

1. Mbale Regional Hospital Institutional Research Committee (MRHIRC), 25/03/2011, ref: REIRC 010/2011
2. University of Liverpool (UK), 05/08/2011, ref: UoL000694
3. Uganda National Council for Science and Technology (UNCST), 07/10/2011, ref: HS 1059

Study design

Placebo-controlled randomized trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the main contact details to request a patient information sheet

Condition

Postpartum hemorrhage (PPH)

Intervention

Once the pregnant women are seen in antenatal clinic and give informed consent to participate in the trial, they will be given either trial pack of misoprostol (600mcg) or identical placebo to be self-administered orally after delivery. She will be trained to take the pills following delivery using adapted teaching tools used successfully in Nepal and Afghanistan. A picture guide on how to take the medication will also be included with the mediation in the study neck purse.

Intervention type

Drug

Phase

Not Applicable

Drug names

Misoprostol

Primary outcome measure

Peri-partum fall in hemoglobin value of over 20% (the outcome of a fall of 2g/dl will also be tested in the pilot) following use of self-administered misoprostol after home birth

Secondary outcome measures

1. The rate of poor maternal and fetal health at 3-5 days after delivery
2. Side effects, and safety (to include transfer to hospital, surgical intervention, blood transfusion and maternal death)

The exact outcomes as well as the power calculations will only be finalized once the pilot study is completed.

Overall trial start date

01/01/2012

Overall trial end date

01/01/2015

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Pregnant women living in the recruitment villages of Mbale district at more than 34 weeks gestation
2. High risk women will not be excluded from the pilot study, even if they state their intention to deliver in a health facility

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

The pilot will allow us determine the primary outcome and thereafter help us determine the number for the main study. The pilot will recruit as many as possible during this time.

Participant exclusion criteria

1. Any pregnant woman with a known allergy to misoprostol or other prostaglandins
2. Any woman under 18 years old (unless she is an emancipated minor)

Recruitment start date

01/01/2012

Recruitment end date

01/01/2015

Locations

Countries of recruitment

Uganda

Trial participating centre

Liverpool Women's Hospital
Liverpool
L8 7SS
United Kingdom

Sponsor information

Organisation

University of Liverpool (UK)

Sponsor type

University/education

Website

http://www.liv.ac.uk

Funders

Funder type

Charity

Funder name

Bill and Melinda Gates Foundation

Alternative name(s)

बिल एंड मिलिंडा गेट्स फाउंडेशन, Bill & Melinda Gates Foundation, Gates Foundation, 比尔及梅琳达·盖茨基金会, BMGF, B&MGF

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data